MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO HF CATHETER 5F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN)(135CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Death (1802)
Date of Event	02/14/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recx0146 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch "retained wire discovered on post post-procedure x-ray inside patient's right ventricle.".

• Brand Name: POWERPICC SOLO HF CATHETER 5F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN)(135CM)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10548290
• Report Number: 3006260740-2020-03288
• Device Sequence Number: 3507247
• Product Code: LJS
• UDI-Device Identifier: 00801741028373
• UDI-Public: (01)00801741028373
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/17/2020
• Report Date (Section F): 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 3395335Q
• Device Lot Number: RECX0146
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/14/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 30 YR
• Date Report Sent to FDA: 02/24/2020